MAUDE Adverse Event Report: CONVATEC INC. NATURA WFR S/HESIVE 57MM; PROTECTOR, OSTOMY

Model Number 401576

Device Problem Insufficient Information (3190)

Patient Problems Discharge (2225); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

End user reported that she developed a small blood filled blister smaller than a dime.After a week or so it broke open and has progress to now being a shallow ulcer about the size of a quarter with a pink moist wound bed and very small amount serosanguinous drainage.She had been changing her wafer every 12 days but due to fluid leaking from wound started changing every 4 days but the wound continue to get bigger.The end user was seen by her doctor and a wound ostomy care nurse (wocn).The wocn showed her how to crust in 3 layers.The end user stated there was still no improvement.Product use discussed.End user to follow up with wocn if no improvement.

• Brand Name: NATURA WFR S/HESIVE 57MM
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5289415
• MDR Text Key: 33276272
• Report Number: 1049092-2015-40108
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 401576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MULTI VITAMINS
• Patient Weight: 91